report of transfusion adverse reaction … of transfusion adverse reaction to blood centers...

REPORT OF TRANSFUSION ADVERSE REACTION TO BLOOD CENTERS

INSTRUCTIONS: Send the form to ALL blood centers that provided blood components to this patient. Timely reporting is important, so that, if appropriate, the blood center may prevent the transfusion of other products from the same donor(s). [Complete areas which are not included in your internal hospital work-up and attach work-up.]

Do you suspect this reaction is the result of an attribute specific to the donor or the blood product? Yes or suspected: Reaction did not result in fatality: Complete this form and forward to the blood center(s) Reaction resulted in fatality: Complete this form, forward to the blood center(s), AND report fatality to FDA No: Stop, do not report Other: Consult with the blood center physician

For blood center use only: Case Identification # Date received / / (mm/dd/yy)

Blood Center Specific Instructions:

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REPORTING FACILITY INFORMATION

Date Submitted / / (mm/dd/yy)

Name of person filling out form

Title of person filling out form

Telephone Number Fax #

Email Address

Reporting Facility

Address

Blood Bank/Transfusion Services Medical Director Phone #

PATIENT/RECIPIENT INFORMATION

Medical record # Name (optional)

Age Date of Birth / / (mm/dd/yy) (optional)

Weight Sex

Attending Physician Attending's Phone #

Admitting or Primary diagnosis

Indication for transfusion

Relevant Severe co-morbidities (if applicable)

Current Medications

Current Respiratory Status

List transfusion history BEFORE reaction (Attach additional sheets if necessary)

List transfusion history AFTER reaction

Any history of transfusion reactions (type and date)

Current Status:

Returned to pre-transfusion status Expired (Transfusion related fatality)*

Still requires support related to transfusion reaction Other/Unknown

* Report to FDA within 24 hours

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BLOOD COMPONENT(S) INFORMATION

* Please list all components that were transfused within the 24 hours prior to the transfusion reaction. (Attach additional sheets if necessary) * For transfusion under massive transfusion protocol or rapid multiple transfusions, please give best estimate of date and time of each unit (Request anesthesiology record if possible).

Blood Supplier

Unit Number

Component Type or

Code

Volume Transfused

Date/Time Transfusion Start

Date/Time Transfusion Stop

Was Product Modified

by Hospital?

/ / (mm/dd/yy) : (hh:mm) am pm


No Yes, Specify:



No Yes, Specify:



No Yes, Specify:



No Yes, Specify:



No Yes, Specify:



No Yes, Specify:



No Yes, Specify:



No Yes, Specify:



No Yes, Specify:



No Yes, Specify:



No Yes, Specify:



No Yes, Specify:



No Yes, Specify:

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REACTION INFORMATION

Date of reaction: / / (mm/dd/yy)

Time reaction started: : (hh:mm) am pmTime transfusion started: : (hh:mm) am pmTime transfusion stopped: : (hh:mm) am pm

Reaction Vital Signs

Pre-Transfusion During Reaction Post Reaction

Date/Time / / (mm/dd/yy) : (hh:mm) am pm



Temperature °C/°F °C/°F °C/°F

Blood Pressure (Systolic) mm Hg mm Hg mm Hg

Blood Pressure (Diastolic) mm Hg mm Hg mm Hg

Pulse bpm bpm bpm

Respiratory Rate bpm bpm bpm

O2 Sat % % %

Symptoms/Signs at time of reaction – Check all that apply

Abdominal pain/cramps [1,4] Angioedema [1] Anxiety [1] Arrythmia [1] Back pain [4] Cardiac arrest [1] Chest pain [4] Chest tightness [1, 3] Chills/Rigors [4] Cough [3, 4] Cyanosis [1, 2, 3] Diarrhea [1] DIC [4]

Dyspnea [1, 2, 3, 4] Edema – pulmonary [2,3] Edema – Pedal [3] Erythema [1] Fever [2, 4] Flushing [1] Headache [3, 4] Hoarseness/Stridor [1] Hypertension [2, 3] Hypotension [1, 2, 4] Hypoxemia [2, 3] Impending doom [1] Jugular venous distension [3]

Loss of consiousness [1] Nausea/Vomiting [1, 4] Oliguria [4] Orthopnea [3] Pain at infusion site [4] Pruritis [1] Shock [1, 4] Substernal pain [1] Tachycardia [1, 2, 3, 4] Tachypnea [2,3] Urticaria [1] Wheezing [1, 4] Widened pulse pressure [3]

Allergic/Anaphylactic [1] | TRALI [2] | TACO [3] | Septic Transfusion Reaction [4]

Suspected Adverse Reaction: Assign priority if more than one possibility*

Allergic/Anaphylaxis Transfusion-related acute lung injury (TRALI)

Septic transfusion reaction

Other, Specify:

Additional information:

* Please refer to the National Healthcare Safety Network Biovigilance Component Hemovigilance Module Surveillance Protocol for complete definitions.

4

https://www.cdc.gov/nhsn/pdfs/biovigilance/bv-hv-protocol-current.pdf

PULMONARY-ALLERGIC-ANAPHYLACTIC REACTION INFORMATION

Risk factors for Acute Lung Injury – Check all that apply

Acute Respiratory Distress Syndrome (ARDS) Aspiration Pneumonia Toxic inhalation Lung contusion Near drowning

Severe sepsis Shock Multiple trauma Burn Acute pancreatitis Cardiopulmonary bypass Drug overdose Volume overload Renal failure

Upper airway obstruction Diffuse alveolar damage Chemotherapy Amiodarone Disseminated intravascular coagulation Radiation to thorax Massive blood transfusion

Additional comments (Other risk factors)

Diagnostics – Check or write values

Pre-TransfusionPre-Tx Values

Post-TransfusionPost-Tx Values

Evidence of hypoxemia

O2 sat ≤ 90% on room air Yes No Not Done Yes No Not Done

PaO2/FiO2 ≤ 300 mm Hg Yes No Not Done Yes No Not Done

Chest X-ray: Bilateral infiltrates Yes No Not Done Yes No Not Done

Chest X-ray: Widened cardiac silhouette (cardiomegaly)

Yes No Not Done Yes No Not Done

Positive fluid balance No Yes, value + ml

BNP (Provide value in pg/mL if done) BNP NT-proBNP


Elevated Central venous pressure greater than 12 mm Hg


Elevated Pulmonary artery pressure greater than 18 mm Hg


Transient decrease White blood cell count Yes No Not Done Yes No Not Done

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Treatment and Clinical Course

Treatment (Mark those treatments that are known

to have been administered and check if yes.)

Response to treatment (Indicate when patient responds to

administered treatment and check if yes.)

Acetaminophen Yes Yes

Antihistamines Yes Yes

Bronchodilators Yes Yes

Diuretics Yes Yes

Epinephrine Yes Yes

Intubation/Ventilatory support Yes Yes

Oxygen supplementation Yes Yes

Steroids Yes Yes

Other (specify): Yes Yes

Additional comments (Attach additional clinical information if available)

If TRALI is suspected, please save an EDTA (purple-top) patient sample

Recipient HLA type:

Recipient HNA type:

Recipient HLA/HNA antibody status:

Donor HLA/HNA antibody result (if performed on unit):

Donor HLA type (if available):

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SUSPECTED BACTERIAL CONTAMINATIONWere the suspect components returned to the blood bank? No Yes

On reinspection does the component present any abnormalities (e.g. clumps, discoloration, hemolysis)? No Yes: Describe: Unevaluable

Suspect component – Source used: Bag Segment Not done

Gram stain performed: Negative Positive Not done

Result (organism):

Culture performed: Negative Positive Pending Not done

Result (organism):

Was a secondary test performed by the hospital for this component (PGD or equivalent)? No Yes, Specify:

Patient’s pre-transfusion blood culture Negative Positive Pending Not done

Date/Time: / / (mm/dd/yy) : (hh:mm) am pm

Result (organism):

Patient’s post-transfusion blood culture result Negative Positive Pending Not done

Date/Time: / / (mm/dd/yy) : (hh:mm) am pm

Result (organism identified if positive):

Does the patient have history of fever or of other infection related to his/her underlying medical condition? No Yes

Was the patient on antibiotics at the time of transfusion? No Yes, Name:

Is the patient currently being treated with antibiotics? No Yes, Name:

Did the patient have an absolute neutropenia (neutrophil less than 500 per μl) prior to transfusion? No Yes

Comments:

FOR BLOOD CENTER USE

Suspected transfusion reaction categorization*

Reaction Allergic/Anaphylactic TRALI TACO Septic Transfusion Reaction Other:

Case definition criteria Definitive Probable Possible

Severity Non-severe Severe Life Threatening Death

Imputability Definite Probable Possible Doubtful Ruled out Not Determined

Notes

Blood Center contact/phone/email

* Please refer to the National Healthcare Safety Network Biovigilance Component Hemovigilance Module Surveillance Protocol for complete definitions.

7

https://www.cdc.gov/nhsn/pdfs/biovigilance/bv-hv-protocol-current.pdf

report of transfusion adverse reaction … of transfusion adverse reaction to blood centers...

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